Pilot Trial of Tubes to Prevent VAP

预防 VAP 的管材试点试验

• 批准号: 8191350
• 负责人: STEVEN A DEEM
• 金额: $ 34.44万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8191350
• 关键词: Acute respiratory failure; Adverse event; Bacteria; Bacterial Pneumonia; Bronchoalveolar Lavage; Clinical; Clinical Trials Design; Confidence Intervals; Critical Illness; Data; Data Collection; Development; Devices; Diagnosis; Effectiveness of Interventions; Emergency Situation; Enrollment; Event; Excision; Extravasation; Functional disorder; Healthcare; Hospital Costs; Hospitals; Hour; Incidence; Injury; Intensive Care Units; Intention; Intervention; Interview; Intubation; Joints; Larynx; Length of Stay; Measures; Mechanical ventilation; Medical; Meta-Analysis; Methods; Metric; Modification; Morbidity - disease rate; Nosocomial pneumonia; Operative Surgical Procedures; Pathway interactions; Patients; Performance; Phase; Phase III Clinical Trials; Pilot Projects; Pneumonia; Polyurethanes; Polyvinyl Chloride; Population; Population Heterogeneity; Positioning Attribute; Prevention; Procedures; Protocols documentation; Questionnaires; Randomized; Randomized Controlled Trials; Relative Risks; Research Personnel; Respiratory Failure; Risk; Risk Reduction; Safety; Sample Size; Suction; Surrogate Endpoint; Techniques; Telephone; Time; Trachea; Trauma; Tube; Validation; Ventilator; base; comparative effectiveness; comparative efficacy; compare effectiveness; cost; cost effectiveness; design; effectiveness trial; endotracheal; mortality; pilot trial; prevent; trial comparing

DESCRIPTION (provided by applicant): The objective of this pilot study is provide data for planning and to establish the feasibility of performing a large, randomized, comparative effectiveness trial of two specially designed airway tubes (endotracheal tubes; ETTs) for the prevention of ventilator-associated pneumonia (VAP). Modification of the material and design of the ETT cuff that is positioned in the trachea, and/or continuous aspiration of subglottic secretions through an extra port positioned between the tube cuff and the vocal chords may prevent leakage of contaminated secretions around the cuff and thereby reduce the risk of VAP. The investigators are planning a phase III, randomized, controlled trial comparing the effectiveness of a polyurethane-cuffed endotracheal tube (PUC-ETT), a polyurethane-cuffed tube that also allows continuous aspiration of subglottic secretions (PUC-CASS-ETT), and a conventional, polyvinylchloride-cuffed endotracheal tube (PVC-ETT) in mechanically ventilated patients with respiratory failure. Prior to initiating the Phase III trial, a smaller pilot study is necessary in order to establish feasibility and to gather data on endpoints in order to establish enrollment rates and project sample size for the definitive trial. For the purposes of planning, a surrogate for VAP, bacterial colonization of the trachea will be assessed from daily quantitative cultures to allow estimation of effect size for the two study devices. Secondary aims include the determination of whether the placement of these ETTs has beneficial effects on other important clinical endpoints, including ventilator-free days, 28-day mortality, intensive care unit and hospital length of stay, and to determine the safety profile of the devices by assessment of upper airway complications persisting after removal of the ETT. Approximately 90 critically ill patients undergoing emergency tracheal intubation in- or out-of-hospital will be randomized to receive one of the three ETTs. VAP will be diagnosed using objective criteria, based on cultures from bronchoalveolar lavage. The safety profile of the tubes will be evaluated using a multi-faceted approach, including short-term objective measures of laryngeal dysfunction and long-term subjective and objective assessment of upper airway problems via phone interview post-hospital discharge, and recording of device-related adverse events. PUBLIC HEALTH RELEVANCE: This pilot study will provide data for planning and establish the feasibility of performing a definitive comparative effectiveness trial of two modified endotracheal tubes designed to reduce microaspiration of subglottic secretions in reducing the risk of ventilator-associated pneumonia. The study will be performed in a diverse population of critically ill patients with acute respiratory failure, and colonization of the lower airways with bacteria will be used as a surrogate for the risk of ventilator- associated pneumonia. The results from this pilot study will be used to estimate sample size and patient enrollment rates for the larger, Phase III trial.

描述（由申请方提供）：本初步研究的目的是为计划提供数据，并确定对两种专门设计的气道插管（气管插管; ETT）进行预防呼吸机相关性肺炎（VAP）的大型、随机、比较有效性试验的可行性。修改气管插管套囊的材料和设计，和/或通过位于插管套囊和声带之间的额外端口持续抽吸声门下分泌物，可防止套囊周围污染分泌物泄漏，从而降低VAP的风险。研究人员正在计划一项III期、随机、对照试验，在呼吸衰竭机械通气患者中比较聚氯乙烯套囊气管插管（PUC-ETT）、一种允许持续抽吸声门下分泌物的聚氯乙烯套囊气管插管（PUC-CASS-ETT）和一种传统聚氯乙烯套囊气管插管（PVC-ETT）的有效性。在启动III期试验之前，有必要进行一项较小的试点研究，以确定可行性并收集终点数据，从而确定最终试验的入组率和项目样本量。出于计划的目的，将通过每日定量培养评估VAP的替代物气管细菌定植，以估计两种研究器械的效应量。次要目的包括确定这些ETT的放置是否对其他重要临床终点（包括无呼吸机天数、28天死亡率、重症监护室和住院时间）具有有益影响，并通过评估ETT取出后持续存在的上气道并发症来确定器械的安全性。约90例在院内或院外接受紧急气管插管的危重患者将随机接受三种ETT之一。VAP将根据支气管肺泡灌洗培养物，采用客观标准进行诊断。将使用多方面的方法评估插管的安全性，包括喉功能障碍的短期客观测量、出院后通过电话采访对上呼吸道问题的长期主观和客观评估，以及记录设备相关的不良事件。 公共卫生相关性：该初步研究将为计划提供数据，并确定对两种改良气管插管进行确定性比较有效性试验的可行性，这些改良气管插管旨在减少声门下分泌物的微抽吸，从而降低呼吸机相关性肺炎的风险。本研究将在不同的急性呼吸衰竭危重患者人群中进行，下呼吸道细菌定植将用作呼吸机相关性肺炎风险的替代指标。这项初步研究的结果将用于估计更大的III期试验的样本量和患者入组率。